Clinical trials are the foundation of modern medicine. They provide vital information on how people respond to new treatments with the main goal of improving health and wellbeing for everyone. However, the effectiveness of this research is at risk when clinical trials do not include people from diverse groups.
If trial participants primarily come from one demographic group, the results may not be applicable to the broader population. This can lead to medicines that are less effective or even harmful for other groups. This issue also weakens scientific quality and continues health inequities. To improve care for everyone, diversity in clinical trials is necessary.
Barriers to Clinical Trial Participation
At Weill Cornell Medicine, all people groups are welcome to participate in clinical trials and our other programs. However, some communities have not had adequate representation for a variety of reasons.
- Lack of trust. A history of discrimination and unethical research has created a deep and lasting legacy of mistrust in the medical system among some populations. Recognizing this mistrust is the first step when encouraging participation.
- Practical and financial challenges. Many potential participants face logistical barriers, such as lack of health insurance, travel expenses, transportation issues and needing to take time off work.
- Lack of awareness and communication gaps. People may not be aware of clinical trials or that they can join. Trials may not be available nearby. Language and cultural barriers can also make it difficult for patients to understand the research and the consent process. Unconscious provider biases can also lead to minority patients not being recruited for trials.
The Consequences of Inadequate Representation for Public Health and Access to Care
When clinical trials do not reflect the population’s diversity, it can affect communities at various levels.
- Worsening health disparities. A lack of diversity makes health differences worse. For example, Black men are 1.5 times more likely to develop prostate cancer and 2.2 times more likely to die from it than white men. However, they make up fewer than 3% of prostate cancer trial participants. This lack of inclusion slows progress in developing treatments that work for those most affected.
- High economic costs. Health disparities cost society trillions of dollars. By 2050, diabetes disparities could cost over $5 trillion and heart disease over $6 trillion. Even a 1% reduction in these disparities through better representation could save more than $40 billion for diabetes and $60 billion for heart disease.
- Limited care access. Excluding groups from studies can block them from accessing new therapies. Medicine approvals often only cover the groups included in the trials.
- Trial failures. Not having enough participants is a frequent cause of clinical trial terminations. Increasing participation from all people groups could help prevent these failures, saving resources and ensuring better data.
Why a Diverse Population in Clinical Research Matters for Everyone
Race, ethnicity, age and sex can all influence how people respond to medications. Without diverse participants, large gaps appear in medical knowledge. A diverse population is important to: - Ensure effectiveness and safety for all. Different ethnic groups may react differently to the same medicines. In studies that lack representation, the findings may not apply to everyone.
- Promote scientific breakthroughs. Diversity can lead to groundbreaking discoveries that help all people. For example, a study involving diverse participants found gene mutations related to cholesterol in Black participants, leading to new cholesterol-lowering drugs.
- Meet regulatory standards. Agencies, such as the Food and Drug Administration and the National Institutes of Health, require clinical trials to include diverse groups.
Strategies to Build Trust and Ensure Inclusivity in Clinical Trials
To improve diversity, everyone involved—researchers, sponsors and care providers—must take action. The goal is to build trust, raise awareness and create a welcoming space for all potential participants.
Effective approaches include:
- Community engagement and outreach. Researchers should engage with communities directly to raise awareness and educate people about clinical trials.
- Inclusive trial design. Clinical trial protocols need to be inclusive from the start, with broader eligibility criteria and offering support, such as reimbursements for transportation, meals and parking, to reduce barriers.
- Clear and respectful consent process. Participants must fully understand the study, including risks and benefits. Consent should be explained in a way that respects culture, age and preferred language, allowing plenty of time for questions.
- Training and cultural sensitivity. Care professionals and research staff should be trained on health equity, cultural sensitivity and reducing unconscious bias. Cultural sensitivity is embedded in Weill Cornell Medicine’s core values and training tools to help research teams become more aware of biases and improve patient interactions.
Conclusion
Ensuring diversity in clinical trials is a fundamental issue of equity. It is everyone’s responsibility to break down barriers and create a research environment where all willing participants have equal opportunities. By doing so, we can advance medical science, reduce health disparities and build a healthier future for everyone.
